Authors
Sunjay S. Kumar1, Amelia T. Collings2, Courtney Collins3, Jennifer Colvin4, Patricia Sylla5, Bethany J. Slater6,7
Abstract
Introduction: The SAGES Guidelines Committee creates evidence-based clinical practice guidelines. Due to existing health disparities, recommendations made in these guidelines may have different impacts on different populations. The updates to our standard operating procedure described herein will allow us to produce well-designed guidelines that take these disparities into account and potentially reduce health inequities.
Methods: This paper outlines updates to the SAGES Guidelines Committee Standard Operating Procedure in order to incorporate issues of heath equity into our guideline development process with the goal of minimizing downstream health disparities.
Results: SAGES has developed an evidence-based, standardized approach to consider issues of health equity throughout the guideline development process to allow physicians to better counsel patients and make research recommendations to better address disparities.
Conclusion: Societies that promote guidelines within their organization must make an intentional effort to prevent the widening of health disparities as a result of their recommendations. The updates to the Guidelines Committee Standard Operating Procedure will hopefully lead to increased attention to these disparities and provide specific recommendations to reduce them.
Keywords: Guidelines · Health equity · Health disparities
Introduction
The SAGES clinical practice guidelines are used by surgeons and patients around the world when considering challenging clinical questions. The Guidelines Committee previously developed a formal, evidence-based methodology informed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach [1]. The GRADE working group has since reconvened and published specific recommendations on how guideline panels should consider issues of health equity during their discussions [2-5]. This Standard Operating Procedure (SOP) update is an effort to incorporate these recommendations into our existing process.
Justice is one of the four core principles of medical ethics along with beneficence, non-maleficence, and respect for autonomy [6]. Inherent to the principle of justice is providing equal access to care and distributing health care resources in proportion to the extent of people’s need. At a societal level we often fall short of this ideal. For example, black Americans experience worse pregnancy outcomes [7], higher death rates with COVID [8], and decreased rates of colon cancer screening [9]. Health disparities may reveal themselves along lines aside from race as well, such as gender, socioeconomic status, sexuality, and rurality. If health equity is not intentionally addressed during guideline development, we run the risk of worsening inequities.
The lack of diversity in clinical trials contributes to health inequity as well. Minority populations are often significantly underrepresented in clinical trials, even when the disease being studied disproportionately affects them [10]. As acknowledged by the National Academy of Sciences, “Racial categories are socially constructed and do not have a biological basis” [11]. However, they also note that because certain genetic factors may be more common among certain ancestral populations, which may correlate with self-identified race, people who self-identify as a certain race may have a different response to medication. For example, populations with more African ancestry tend to require higher doses of warfarin than those with more European ancestry to reach their therapeutic target [12]. Similarly, populations with more Asian ancestry tend to require lower doses. However, the dosing algorithms were based on studies conducted in patients of primarily European ancestry so these genotypic differences were neither known nor recognized until the 2000s. Patients with African and Asian ancestry initiating warfarin therapy were likely underdosed and overdosed, respectively, for decades. While there is no evidence of such genotypical effects on response to surgical therapy, we will not be able to uncover any such differences without increasing the diversity of the populations in clinical trials.
The Guidelines Committee recognizes that there are many disparities in access and delivery of surgical care and every effort should be made to highlight, reduce, and ultimately eliminate these disparities. We created this SOP with the goal of updating our process to better address issues of health equity.
Methods
The process described in this paper is based on the GRADE Equity Guidelines series published in the Journal of Clinical Epidemiology [2-5]. This paper will make frequent reference to the SAGES Guideline Development Standard Operating Procedure which has been published previously [1]. This process was developed in conjunction with the current Guidelines Committee leadership, past and present Guidelines Committee fellows, and members of the newly formed Health Equity taskforce. For an overview of the steps for guideline development, see Figure 1.
Results
Step 0: Project Conception and Team Assignments
This step involves choosing the subject for new guideline topics and assigning members to said project. There are three changes the committee will make to better address issues of health inequity: 1) Efforts will be made to improve the diversity of the guidelines committee membership. A more diverse committee membership will help reduce “blind spots” with regards to existing or potential health disparities. 2) The committee will make an intentional effort to investigate disease processes with known disparate health outcomes with a goal of making recommendations that will reduce these disparities. The newly created Equity Taskforce will assist in generating ideas for such projects. 3) When identifying members for the expert panel, special effort will be made to seek out experts who work towards reducing health disparities for that disease process. Similarly, special effort will be made to include patient advocates from diverse backgrounds to ensure marginalized groups are represented in the guidelines development process.
Step 1: Key Question(s), Exclusion/Inclusion Criteria Generation
This step entails creating key questions in the Population, Intervention, Comparison, Outcome (PICO) format. A preliminary literature search for publications on health disparities for the disease process will be used to inform the design of key questions and to write the section of the manuscript described in steps 9 and 10. Populations with known or plausible health disparities pertaining to the disease process of interest will be included as subgroups within the population. The following prompts from Oxman et al. identified by Welch et al. as being particularly relevant to the GRADE process will be utilized routinely for every PICO question [2,13]:
- Are there groups or settings that might be disadvantaged in relation to the problem or intervention of interest?
- Are there plausible reasons for anticipating differences in the relative effectiveness of the intervention for disadvantaged groups or settings?
- Are there different baseline conditions across groups or settings that affect the absolute impact of the intervention or the importance of the problem for disadvantaged groups or settings?
- Are there important considerations that people implementing the intervention should consider to ensure that inequities are reduced, if possible, and that they are not increased?
The PROGRESS-Plus framework will be utilized to identify such populations (Figure 2) [14].
Identifying such populations from the outset will allow us to collect data for these groups and potentially tailor recommendations to those groups of patients.
Steps 3 & 4: Abstract Review & Full Text Review
A tenet of the GRADE process is to use the highest level of evidence available for a given question. For example, in the design of some key questions randomized controlled trials (RCTs) will be prioritized over observational studies. This may lead to exclusion of observational studies during abstract review and full text review.
However, if unable to identify RCT data addressing health disparities, observational and even non-comparative data addressing health inequities can be reviewed separately. While these papers may not meet criteria to be included in meta-analysis, they can be used to better understand existing disparities or differences in disease prevalence. These studies, along with studies identified during the search dedicated to health disparities, will be used in the section described in Steps 9 and 10.
Step 5: Data Extraction
During the guidelines development process, the committee routinely extracts age, gender, and BMI for the intervention and comparison arms. However, not all health disparities break down along these lines. Therefore, the proportion of patients belonging to different racial groups and any subgroups identified in Step 1 will be recorded as well.
Steps 9 & 10: Guidelines Development and Guidelines Manuscript
We anticipate the surgical literature will be missing direct, scientific evidence of the benefits of simple, reasonable initiatives, such as decreasing barriers to care for disadvantaged groups. While the GRADE approach may not permit us to make formal recommendations in such settings, we will still make good-practice statements where applicable.
Previously, our guidelines were largely structured around communicating the evidence for outcomes deemed critical to decision-making, the expert panel’s reasoning when formulating decisions, and future research needs. New guidelines will have a section dedicated to health disparities for the given disease process or intervention, which will be written in conjunction with a member of the Health Equity Taskforce. The content of this section will be dictated by the existing evidence regarding health disparities. For example, in cases of documented health disparities with an unclear cause, the panel will make research recommendations to work towards uncovering the underlying reason for the disparity (Table 1).
Naturally this will have some overlap with future research needs as well as implementation and monitoring concerns; however, we feel that the importance of these issues warrants their repetition.
Step 13. Member and Public Review
Prior to publication a near-final version of the guidelines is available online for a period of SAGES member and public review. During this time, we will make one more attempt at seeking feedback from experts and patient advocates who were unavailable to participate in the panel discussions.
Discussion
Many surgical organizations including the European Association for Endoscopic Surgery, the Eastern Association for the Surgery of Trauma, and the Society of Thoracic Surgeons publish clinical practice guidelines, but to our knowledge we are the first surgical organization to optimize our guidelines development process to address health disparities. We believe that addressing issues of health equity is essential to the future of guideline development and hope that other societies will enthusiastically join us in this endeavor.
The American Society for Metabolic and Bariatric Surgery and the International Federation for the Surgery of Obesity and Metabolic Disorders provide an excellent example of how guidelines can intelligently address health disparities [15]. Their 2022 joint guidelines on Indications of Metabolic and Bariatric Surgery note “In the Asian population the prevalence of diabetes and cardiovascular disease is higher at a lower BMI (body mass index) than in the non-Asian population. Thus, BMI risk zones should be adjusted to define obesity at a BMI threshold of 25–27.5 kg/m2 in this population. Therefore, in certain populations access to MBS should not be denied solely based on traditional BMI thresholds.”
The GRADE working group which published the Equity Series acknowledged that equity can potentially be addressed at each step in the process. They ultimately focused their attention on the most relevant steps. Similarly, to make the most effective use of this volunteer committee’s resources we have chosen to update the steps that will allow us to make the greatest impact on issues of equity. As the committee grows facile with the new approach, we will undoubtedly identify other ways to improve the guidelines development process.
The existing SAGES Guidelines Committee SOP is a robust methodology for generating evidence-based clinical practice guidelines. The updates outlined in this paper will facilitate future guidelines’ ability to reduce health disparities in pursuit of truly just care.
Authors affiliations
Sunjay S. Kumar1, Amelia T. Collings2, Courtney Collins3, Jennifer Colvin4, Patricia Sylla5, Bethany J. Slater6,7
- Department of Surgery, Thomas Jefferson University 1Hospital, Philadelphia, PA, USA
- Hiram C. Polk, Jr. Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA
- Department of Surgery, Ohio State University Wexner Medical Center, Columbus, OH, USA
- Department of Surgery, University of Cincinnati, Cincinnati, OH, USA
- System Chief, Division of Colon and Rectal Division, Mount Sinai Health System, New York, NY, USA
- Department of Surgery, University of Chicago Medicine, Chicago, IL, USA
- Department of Surgery, University of Chicago, Chicago, IL, USA
Declarations
Disclosures Drs. Kumar, Collings, and Collins have no financial ties to disclose, Dr. Colvin has received consulting fees from Ethicon, unrelated to this manuscript, Dr. Sylla has received consulting fees from Ethicon, Safeheal, RedDress, Astellas, and Exero and holds leadership roles within SAGES, Dr. Slater has received consulting fees from Cook Medical, Hologic, and Metabolic Solutions and holds leadership roles within SAGES and the International Pediatric Endosurgery Group. Sunjay S. Kumar, Amelia T. Collings, Courtney Collins, Jennifer Colvin, Patricia Sylla, and Bethany J. Slater have no conflicts of interest or financial ties to disclose.
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Figure 1. Overview of steps for guideline development
Steps for guideline development, from the previously published SAGES Standard Operating Procedure, with stars indicating steps being modified to address issues of health inequity [1].
Figure 2. PROGRESS plus acronym
Important factors to consider in health inequities, from O’Neill et al. [14]
Table 1. Potential recommendations based on available evidence
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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.
Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.